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If entering the project management or regulatory department of a company that makes and sells medical devices, what does employees usually do to maintain the licenses for manufactures from the FDA? Is the maintenance procedure very complicated?
Posted : 13/02/2022 5:23 pm
I do not believe that additional approval would be required for a medical device that has already had a PMA. However, all medical device manufacturers are subject to audit from the FDA. Audits can be conducted at certain intervals depending on the type of product or company. They will look at the quality systems put in place to make sure all the requirements are met. A medical device manufacturer will also want to keep up with certifications like ISO 13485
Posted : 13/02/2022 10:00 pm
